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1208871

Celgene Corporation — FEI 3004991673

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 16, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Summit, NJ (United States)

Facility

Other inspections at this facility

  • 1275526 (VAI Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1236864 (VAI Fri Dec 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1247735 (NAI Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1228973 (NAI Wed Jan 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1165563 (NAI Mon Mar 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
141321 CFR 211.42(c)(5)Mfg / Processing Operations Area
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
176721 CFR 211.137(a)Expiration date lacking